GMPs and AERs dominate 2007 regulatory scene

The final rule of the Good Manufacturing Practices (GMP) legislation came in this year and is set to provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing. Also rolling into execution this year was the Adverse Events Reporting (AER) bill. Both items of legislation have brought the promise of enhancing industry's credibility without overly stifling ingredients' journey from development to the market place. In June, the US Food & Drug Administration (FDA) issued the final rule on Good Manufacturing Practices (GMPs), which many said was the most important regulatory development for the dietary supplement industry in over a decade. A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been the missing link in governance of the dietary supplement industry. While the road has been long for these requirements to become legislation, it made be arduous still for those manufacturers that have not been using food GMPs as a point of reference up until now. Dietary supplement trade associations have been involved in the process of bringing GMPs to life, insofar as providing comments and input to FDA. While many were nervous as to what the regulations would look like when finally issued, it seems the result has been met with approval. The main difference between food GMPs and the new ones for the dietary supplement industry is that over and above checking for sanitary and consistent products, the new GMPs also ensure purity, identity and strength of composition. Also, because the new GMPs put the burden solely on the manufacturer, the outcome may well be that there is increased pressure from these very manufacturers on what they expect of their suppliers. The effective date of the interim GMP rule is August 24, 2007. FDA is making allowances for small businesses by giving them extra time to comply. As such, there is a three-year phase-in for small businesses. Those companies with more than 500 employees will have until June 2008 to comply, while those companies with less than 500 employees have until June 2009 to comply. Finally, those with fewer than 20 employees have until June 2010 to comply with the regulations. The AER bill was signed into law by President Bush this time last year, and has been applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers. This amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports (AERs). The bill requires supplement labels to include a telephone number for the reporting of serious adverse events, and obliges supplement companies to pass on these reports to FDA within 15 days. To begin with, a company has to be able to define and identify what constitutes a serious adverse events report. This then triggers the 15-day process of getting information to the FDA. Smaller companies will not have to worry about taking on all the responsibility for setting up an adverse events reporting system, as contract manufacturers can take calls for companies. This has in turn opened up further business opportunities for such third party service providers.